QA Specialist III
GILEAD - San Dimas, CA
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Job Advertised by Pharmadiversity Job Board - : Minimum of a Bachelors degree in a related field (physical science, engineering or management) with minimum of 6 years of progressively responsible quality systems experience in related field. MA or MBA degree and minimum 4 years of relevant experience preferred. Minimum of 2 years auditing experience required. CQA certification is a plus. Essential Duties and Job Functions: Performs a wide variety of activities to ensure compliance with applicable regulations. Conduct and lead supplier quality assessments/audits as well as internal audits. Lead and/or participate on Supplier Quality management process improvement projects with internal stakeholders and with suppliers. Assist in managing regulatory and client inspections. Monitor applicable regulatory trends, industry best practices and communicate to applicable process owners. Participate in supplier risk assessments and supplier analysis/evaluation. Support managing of Supplier Quality Agreements. Monitor and issue monthly performance metrics related to audits (regulatory, internal and external). Work with cross-functional teams in developing responses and solutions to audit observations/findings. Requires at least 50% travel time. Knowledge, Experience and Skills: Sound knowledge and understanding of pharmaceutical industry regulations and expectations, specifically FDA Aseptic Guidance for Industry, CFR, European GMPs/Annexes and other international regulatory requirements. Demonstrate working knowledge and application of effective pharmaceutical quality system based on ICH Q8, Q9, and Q10. Sound knowledge and experience in Aseptic Processing environment. Experience related to Supplier Quality Management. Ability to interpret Quality standards, principles, concepts and industry practices. Ability to communicate clearly and professionally both in writing and verbally. Ability to independently identify compliance risks and escalate when necessary. Knowledge of Change Control and CAPA systems. Knowledge of computer systems for word processing, data analysis and custom databases such as Trackwise. Requires strong attention to details in implementing and reviewing documents, establishing priorities and meeting deadlines. Ability to collaborate and manage cross-functional teams. Demonstrated interpersonal skills including strong negotiation and presentation skills.. br/ br/ * For application attention if web source is requested please use PharmaDiversity or PharmaDiversity Job Board. br/ br/ APPLY FOR THIS JOB by going to ...http://www.pharmadiversityjobboard.com/view_job.php?post_id=587818&tag=aje
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